Table 1.
Scoring of severity of solicited and unsolicited adverse events.
Fig 1.
Volunteer Flow Chart (CONSORT diagram).
Table 2.
Baseline Demographics by Study Groups.
Table 3.
Number of subjects (percentage) experiencing Solicited Adverse events by study arms and intensity levels.
Table 4.
Geometric Mean Titre (GMT) at 95% Cl for PfF2-specific antibodies elicited after vaccination with 10μg, 25μg and 50μg JAIVAC-1 and Hepatitis B vaccine.
Table 5.
Geometric Mean Titre (GMT) at 95% Cl PfMSP-119-specific antibodies elicited after vaccination with 10μg, 25μg and 50μg JAIVAC-1 and Hepatitis B vaccine.
Fig 2.
Antibodies to PfF2 and PfMSP-119 after vaccination with JAIVAC-1.
Anti-PfF2 (A) and PfMSP-119 (B) antibody levels measured by ELISA. Geometric mean antibody levels (AU) to recombinant PfF2 and PfMSP-119 measured by ELISA in sera collected from Day 0 to Day 365 in 10μg, 25μg, and 50μg JAIVAC-1/Montanide ISA720 and Hepatitis B vaccine recipients. Study participants were immunized on Days 0, 28 and 180 and sera were collected on Days 0, 28, 56, 180, 208 and 365. Antibody levels measured by ELISA were expressed as Geometric Mean Titres (GMT) for the 10 subjects. Anti-PfF2 specific IgG subclass profiles in the sera of individuals vaccinated with 25μg (C) and 50μg (D) JAIVAC-1 as measured by ELISA are shown.
Table 6.
Number of responders to antigen PfF2 and PfMSP-119 in 10μg, 25μg and 50μg JAIVAC-1/Montanide ISA720 and Hepatitis B vaccine recipients.
Fig 3.
Recognition of native antigens in blood stage P. falciparum schizonts.
Serum from one representative subject immunised with JAIVAC-1 was used to detect native PfMSP1 and EBA 175 in P. falciparum schizonts by Immunofluoroscence Assay (IFA). The punctate staining at the apical end of merozoites in late-stage schizonts reflects the known distribution of EBA 175.
Fig 4.
Dose-dependence (A) and kinetics (B) of antibody response as measured by IFA using sera from subjects who received 10μg, 25μg and 50μg of JAIVAC-1 and Hepatitis B vaccine. The arrows indicate days of immunisation.
Fig 5.
Vaccine induced in vitro Growth Inhibitory Activity (GIA).
The percent growth inhibition in cultures was measured by pLDH using two different strains of P. falciparum (CAMP and 3D7). (A) and (B) represent the percent growth inhibition of P. falciparum CAMP and 3D7 parasite strains after addition of 10 mg/ml purified IgG from sera of Day 0 and Day 208 of 50μg of JAIVAC-1 vaccine and Hepatitis vaccine group. (C) and (D) represent the average percent growth inhibition of—P. falciparum parasite strains CAMP and 3D7 with Day 0 and Day 208 sera from individuals immunized with 50μg of JAIVAC-1 and Hepatitis vaccine.